Pregabalin (Lyrica) Action In Neuropathic Pain Syndrome (PAINS): A Post Marketing Surveillance Study On Efficacy, Safety And Tolerability Of Pregabalin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,278
- 主要终点
- Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
研究概览
简要总结
This study is being conducted as a regulatory requirement post initial marketing authorization. This is primarily a safety study. This was an open label study and patients were enrolled once the decision to prescribe the medication was made by the Investigator.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years old and above diagnosed with neuropathic pain.
排除标准
- •Patients that are pregnant and lactating; and patients with known hypersensitivity to pregabalin or its related components.
研究组 & 干预措施
Open-Label
This study was open-label with only one treatment group. Pregabalin was prescribed in accordance with usual clinical practice.
干预措施: Pregabalin (Drug)
结局指标
主要结局
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
时间窗: Baseline through Final Visit (Week 4)
Number and severity of adverse events, including serious adverse events. If the same subject had more than one occurance in the same preferred term event category, only the most severe occurrence was taken.
Discontinuations Due to Adverse Events
时间窗: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)
Discontinuations due to adverse events by MedDRA system organ class and preferred term.
次要结局
- Change From Baseline in Visual Analogue Scale (VAS) Score(Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4))
- VAS Pain Score at Baseline (BL) and Second Visit(Baseline, Second Visit (Week ≥ 2))
- VAS Pain Score at Baseline and Final Visit(Baseline, Final Visit (Week 4))
- Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits(Second Visit (Week ≥ 2), Final Visit (Week 4))
- Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits(Second Visit (Week ≥ 2), Final Visit (Week 4))
- Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit(Second Visit (Week ≥ 2), Final Visit (Week 4))
- Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit(Second Visit (Week ≥ 2), Final Visit (Week 4))
- Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist(Second Visit (Week ≥ 2), Final Visit (Week 4))
- Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit(Second Visit (Week ≥ 2), Final Visit (Week 4))